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New procedure for foot stress fractures shows promise in 148-Patient study

NCT ID NCT03087396

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 148 people who had a procedure called Subchondroplasty® for stress fractures or bone defects in the foot or ankle. Researchers tracked pain, function, and satisfaction for up to 24 months after surgery. The goal was to see how well the procedure helps patients recover in everyday life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

148 people

The number who actually took part.

Started

Mar 2017

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 140 subjects, each with at least one bone marrow lesion (BML) in any of the bones of the foot and/or ankle who have elected to undergo or have undergone the Subchondroplasty (SCP) procedure will be enrolled in the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has at least one bone defect such as a bone marrow lesion (BML), cyst or stress fracture confirmed by diagnostic imaging * Surgeon considers the patient appropriate for the SCP procedure * Subject provides voluntary signature on the Institutional Review Board (IRB) approved Informed Consent * Subject is at least 18 years of age * Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to complete outcome forms via the internet, telephone or regular mail Exclusion Criteria: * Subject is pregnant at the time of surgery * Subject is incarcerated * Subject is involved in active litigation related to the condition being treated

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Stress solitary bone cyst

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insufficiency fractures Stress fracture Stress fracture, ankle, foot and toes

Contacts and locations

Locations

  • Capital Orthopaedics and Sports Medicine

    Clive, Iowa, 50325, United States

  • Eisenhower Desert Orthopedic Center

    Rancho Mirage, California, 92270, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • OrthoArizona

    Mesa, Arizona, 85206, United States

  • OrthoNorcal

    Capitola, California, 95010, United States

  • Podiatry Center of the Lehigh Valley

    Bethlehem, Pennsylvania, 18018, United States

  • Premier Orthopaedics & Sports Medicine

    Exton, Pennsylvania, 19341, United States

  • Rothman Institute

    Bryn Mawr, Pennsylvania, 19010, United States

  • St. Paul's Hospital (Providence Health)

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Stanford University Medical Center, Orthopedics

    Redwood City, California, 94063, United States

  • The CORE Institute

    Sun City, Arizona, 85351, United States

  • University of California, Davis

    Sacramento, California, 95817, United States

More trials for these conditions

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